C.a.p.d. Automatic Heater #pdc 2000 Hcp
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K821328 FDA 510(k)
- FDA Product Code
- KPF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5630 FDA 510(k)
- Regulation Number
- 876.5630 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The System, Dialysate Delivery, Semi-Automatic, Peritoneal (per FDA nomenclature) is designed to heat and deliver dialysate solutions for continuous ambulatory peritoneal dialysis (CAPD). It maintains precise temperature control to ensure optimal fluid warming before infusion into the peritoneal cavity, supporting safe and effective peritoneal dialysis therapy.
This device is supplied as a reusable medical system and is intended for use in clinical settings, including hospitals and dialysis centers. It operates under sterile conditions and requires proper storage and handling as outlined in its instructions. The CAPD Automatic Heater PDC 2000 HCP holds an FDA 510K clearance (K821328) under product code KPF, adhering to regulatory standards for peritoneal dialysis equipment. No MRI safety information or single-use designation is specified.
Frequently asked questions
What is the CAPD Automatic Heater PDC 2000 HCP used for?
The CAPD Automatic Heater PDC 2000 HCP is designed specifically for continuous ambulatory peritoneal dialysis (CAPD). It heats and delivers dialysate solutions at a precise, controlled temperature before infusion into the peritoneal cavity. This ensures the fluid is warmed optimally, supporting safe and effective peritoneal dialysis therapy in clinical environments like hospitals and dialysis centers.
Is the CAPD Automatic Heater PDC 2000 HCP reusable or single-use?
The CAPD Automatic Heater PDC 2000 HCP is supplied as a reusable medical system. It is intended for use in clinical settings and requires proper maintenance, cleaning, and storage as outlined in its instructions to ensure sterility and functionality over repeated use.
How is the sterility of the CAPD Automatic Heater PDC 2000 HCP maintained?
The device operates under sterile conditions during use, but its reusable nature means sterility is maintained through adherence to the manufacturer’s instructions for cleaning, disinfection, and storage. These protocols are critical to preventing contamination and ensuring safe operation in peritoneal dialysis procedures.
What regulatory clearance does the CAPD Automatic Heater PDC 2000 HCP hold?
The CAPD Automatic Heater PDC 2000 HCP holds FDA 510(k) clearance under the product code KPF, with the clearance number K821328. This classification confirms it meets regulatory standards for peritoneal dialysis equipment and is substantially equivalent to a predicate device as determined by the FDA.
What storage and handling requirements apply to the CAPD Automatic Heater PDC 2000 HCP?
The device must be stored and handled according to the manufacturer’s instructions to preserve its functionality and sterility. This includes proper cleaning, disinfection, and storage conditions to prevent damage or contamination, ensuring it remains operational for repeated use in peritoneal dialysis treatments.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP - Innolitics, FDA Browser - Cleared 510 (K) - C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP ..., C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP 510(k) K821328 - fda.report, Medionics Internatio… — 6 FDA 510 (k)s · DeviceClearance, MEDIONICS INTERNATIONAL, INC. FDA Filings - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K821328 | Class II | Active |
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Manufacturer
- Manufacturer
- Medionics International , Ltd.
Sources (1)
- FDA 510(k) K821328 24 fields · synced Oct 1, 2026